Clinical relevance of the antimicrobial resistance testing in the treatment of chronic wounds with antiseptics
- Conditions
- Decubitus, acute or chronic wounds (open wounds existing = 14 days)Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2018-003321-29-DE
- Lead Sponsor
- RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1.Age = 18 years
2.Decubitus OR secondary healing acute and chronic wounds
3.Positively tested wound swab for bacteria (incl. multi-resistant bacteria)
4.Patient is capable of understanding the nature, significance and consequence of the clinical trial
5.Given written consent
6.Women of child bearing potential (WOCBP) who apply appropriate methods of contraception throughout the duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1.Occlusive dressing (e.g. VAC)
2.Pregnant or lactating women
3.Known allergies against investigational products
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To improve the current and local standard antiseptic treatment by adjusting the antiseptic agent to the antimicrobial resistance testing result, accordingly. Currently, resistance testing will only be performed for the treatment with antibiotics.;Secondary Objective: Not applicable.;Primary end point(s): Reduction of bacteria;Timepoint(s) of evaluation of this end point: Screening, Visit 1, Visits each week until discharge or wound healing
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Wound related adverse events<br>•Improvement of wound healing (scoring questionnaires)<br>•Correlation of laboratory parameters<br>•Length of hospital stay<br>•Use of antibiotics<br>•Length of bed confinement<br>;Timepoint(s) of evaluation of this end point: Screening, Visit 1, Visits each week until discharge or wound healing